Category: Generic Drugs

Illustration of a cartoon man jumping from one oversized blister pack of pills to another

Stopping the Pharmaceutical “Product Hop”

Phebe Hong 4 Comments

By Phebe Hong

It happens every year like clockwork: Apple releases a new iPhone, and then hordes of people rush to buy it, despite still owning perfectly functional older models. We’re willing to shell out hundreds of dollars for a few extra camera features and new colors. As a result, Apple profits. A similar phenomenon is occurring in the drug industry, but with less consumer choice and more dire consequences.

“Product hopping” in the drug industry occurs when a pharmaceutical manufacturer winds down production of an old drug formulation whose patent expiration date has passed or is approaching. The company then forces or persuades patients to switch prescriptions to the drug’s new – and newly patented – formulation. A successful “product hop” extends a pharmaceutical manufacturer’s monopoly and therefore its ability to charge high prices.

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Photograph of a gavel and three open books

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari 1 Comment

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

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hand reaching for blue pills

The Rotten U.S. Antiparasitic Drug Market

Rahul Nayak Leave a comment

Recently, there has been a lot of media attention on galling price hikes of generic drugs.

Historically, the social contract in pharmaceutical pricing has been tolerating expensive brand-name drugs while they have been on patent (a government-granted monopoly), followed by allowing low cost generics to rush to market after patent expiration. Yet these norms are now being challenged in the setting of increased generic manufacturer consolidation and single-source generic drugs.

Probably the most well known example is the case of Martin Shkreli (the so-called “Pharma Bro”) and Turing Pharmaceuticals, which bought out the rights of pyrimethamine (Daraprim), a key treatment for Toxoplasmosis and other infectious diseases, raising the price from $13.50 per pill to $750 per pill.

Note that even the pre-price hike price is significantly more than people other countries pay. In the UK it costs only $0.66 per pill and in Australia it is $0.18 per pill.

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Tertiary Patents: An Emerging Phenomenon

Jonathan Darrow Leave a comment

By Jonathan J. Darrow

Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,” which have the potential to further delay and discourage market entry in the context of drug-device combination products.

Combination products are defined by the U.S. Food and Drug Administration (FDA) to include therapeutic products that combine a drug with a device, such as an inhaler or injector pen. These products can sometimes offer life-changing or life-sustaining treatment, as with naloxone (Narcan) for opioid overdose or epinephrine (EpiPen) for severe allergic reactions. In recent years, these and other similar products have been the subject of substantial controversy related to their prices and prolonged lack of generic competition.

To investigate the potential role of patents on the prices and exclusivity periods of drug-device combination products, two researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School (where I hold a faculty appointment) conducted a comprehensive evaluation of drug-device combination patents registered with the FDA. They found that patents related to drug delivery devices have tripled since the year 2000 and contribute a median of five years of additional market exclusivity to those products (subject, of course, to potential judicial or administrative patent invalidation). Furthermore, the researchers identified a subset of 31 products having only device patents (i.e., having no primary or secondary patents), and found that these patents were scheduled to expire a median of 17 years after FDA approval. Read More

Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

AGENDA NOW AVAILABLE: Sixth Annual Health Law Year in P/Review imageHealth Law Year in P/Review
December 12, 2017 8:30 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

AGENDA NOW AVAILABLE: Sixth Annual Health Law Year in P/Review imageHealth Law Year in P/Review
December 12, 2017 8:30 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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Roche and City of Hope Claim Pfizer Biosimilar Version of Trastuzumab Will Infringe “At Least” 40 Patents

James Love Leave a comment

By James Love

On November 17, 2017, Genentech, a subsidiary of the giant Swiss drug company Roche, together with City of Hope, a charity, filed a complaint in a U.S. District Court, seeking an injunction to block introduction of a Pfizer biosimilar version of Herceptin (INN: trastuzumab), as well as other remedies to infringement, including compensation for Roche’s lost profits if competition occurs. The complaint (Genentech vPfizer, 17-cv-1672, U.S. District Court, District of of Delaware (Wilmington), filed November 17, 2017) illustrates the complexity of the patent landscape on a drug placed on the market more than 19 years ago and the need for compulsory licensing of patents.

Trastuzumab is a very important drug for the treatment of breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+). My wife was treated with trastuzumab for several years, and is currently on a follow-on Roche treatment named Kadcyla, which is a combination of trastuzumab and the small molecule DM1. (DM1 is an NIH funded drug now off patent).

The early development of trastuzumab was dramatic, and documented in such accounts as Robert Bazell’s very readable book, Her-2: The Making of Herceptin, a Revolutionary Treatment for Breast Cancer, published in 1998, and the 2008 movie Living Proof, starting Harry Connick, Jr..  Bazell’s book was referred in the New York Times and the New England Journal of Medicine. The Bazell book and the Living Proof movie provide a dramatic account of the unwillingness of Genentech to invest in the research that led to the approval of trastuzmab, and the role of the Revlon Foundation to support Dr. Dennis Slamon’s critical work at UCLA.

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REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

AGENDA NOW AVAILABLE: Sixth Annual Health Law Year in P/Review imageHealth Law Year in P/Review
December 12, 2017 8:30 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

REGISTER NOW (12/12)! Sixth Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

AGENDA NOW AVAILABLE: Sixth Annual Health Law Year in P/Review imageHealth Law Year in P/Review
December 12, 2017 8:30 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

Read More

Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of June. The selections feature topics ranging from physicians’ views of the Sunshine Act; to a biomarker-based drug development case study of CETP inhibitors, to the potential return on public investment in detecting adverse drug effects. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Chimonas S, DeVito NJ, Rothman DJ. Bringing Transparency to Medicine: Exploring Physicians’ Views and Experiences of the Sunshine Act. Am J Bioeth. 2017;17(6):4-18.
  2. Dong K, Boehm G, Zheng Q. Economic Impacts of the Generic Drug User Fee Act Fee Structure. Value Health. 2017;20(6):792-8.
  3. Hey SP, Franklin JM, Avorn J, Kesselheim AS. Success, Failure, and Transparency in Biomarker-Based Drug Development: A Case Study of Cholesteryl Ester Transfer Protein Inhibitors. Circ Cardiovasc Qual Outcomes. 2017;10(6).
  4. Huybrechts KF, Kesai RJ, Park M, Gagne JJ, Najafzadeh M, Avorn J. The Potential Return on Public Investment in Detecting Adverse Drug Effects. Med Care. 2017;55(6):545-51.
  5. Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-Year Impacts Of The Affordable Care Act: Improved Medical Care And Health Among Low-Income Adults. Health Aff (Millwood). 2017;36(6):1119-28.
  6. ‘t Hoen EFM, Boulet P, Baker BK. Data exclusivity exceptions and compulsory licensing to promote generic medicines in the European Union: A proposal for greater coherence in European pharmaceutical legislation. J Pharm Policy Pract. 2017;10:19.